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Clinical Scientist IV
Ref No.: 19-07470
Location: South San Francisco, California
Clinical Scientist IV
South San Francisco, CA

JOB DESCRIPTION

Seeking a candidate with a bachelor's degree and preferably an advanced clinical/science degree (e.g. PharmD, PhD, MPH) with at least 4 years of industry experience to work on a late-stage molecule for ulcerative colitis and Crohn's disease. Multiple ongoing Phase 3 studies with data readouts for ulcerative colitis next year.

Cross-Functional Team Membership
  • Participates in the relevant Clinical Science Team (CST)
  • Participates as a standing member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient clinical development (CD) plan execution
Clinical Development Plan Implementation
  • Provides clinical support across all relevant studies and programs:
  • Participates in ongoing CST and relevant sub-team meetings, other interactions and communications
  • Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
  • Responds to questions from other internal and external parties regarding assigned studies and programs
  • Helps coordinate the successful completion of documents with other groups
  • Collaborates with clinical science, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc.
  • Works with clinical science, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
  • Assists in responding to health authority inquiries
  • Works closely with clinical science, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting
  • Supports clinical science, regulatory and other internal partners/stakeholders with completion of clinical study reports
  • Completes other special projects, as and when assigned, or otherwise requested
  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines
QUALIFICATIONS & EXPERIENCE:
  • Bachelor's degree required (life science preferred)
  • Advanced clinical/science degree is preferred (e.g. PharmD, PhD, MPH)
  • 4 or more years pharma/biotech industry experience
  • Data listing review experience
  • Experience working on a clinical team (or equivalent)
  • Has extensive knowledge of clinical research and has successfully worked across Phase II – III drug development projects
  • Broad experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, Client, competitor data, etc.)
  • Comprehensive understanding of product and safety profiles
  • Well versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
ABILITIES:
  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
  • Outstanding attention-to-detail
  • Has knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target accomplishment of such
  • Strong interpersonal, verbal communication and influencing skills
  • Outstanding written communication skills
  • Strong business presentation skills; is comfortable and effective when presenting to others, internally or externally
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others.
  • Has proven experience and skills working with multidisciplinary teams